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In this observational study, data from the recent past of patients with type 2 diabetes mellitus and chronic kidney disease will be studied.
Type 2 diabetes mellitus (T2DM) is a condition in which the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels. About half of people with T2DM also have a condition called chronic kidney disease (CKD). In people with CKD, the kidneys' ability to work as how it should decreases over time.
In this study, researchers want to learn more about the CKD in T2DM patients in Alberta, Canada. This will help them to know the chances to improve the care of these patients.
The researchers will look at the health information from adult men and women in Alberta who were diagnosed with T2DM before 2018 and visited a doctor to have check-ups in 2018. They will find out about how many of these people had CKD and how severe their CKD was. The researchers will collect data about the age and gender of these patients, how long they had T2DM and if they had other related medical problems. The researchers will also learn how these patients were treated based on their kidney condition and how much money was spent on these treatments.
This study will collect information from the health records of about 270,000 patients with T2DM who were living in Alberta, Canada. This information will come from the Alberta Kidney Disease Network (AKDN) database. Besides this data collection, no further tests or examinations are planned in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 Diabetes Mellitus patients with Chronic Kidney Disease | Canadian patients with type 2 diabetes mellitus data will be collected retrospectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Retrospective population-based study utilizing administrative data without any intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Type 2 Diabetes Mellitus (T2DM) patients with Chronic Kidney Disease (CKD) in database. | Percentage of T2DM patients with CKD as per hemoglobin A1C, and stage of CKD as defined by a) baseline Kidney Disease: Improving Global Outcomes (KDIGO) guidelines CKD category, and b) eGFR ≥25 to <75 mL/min/1.73 m2 and ACR ≥30 to ≤5,000 mg/g. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive analyses of clinical characteristics of patients in database. | Duration of diabetes, comorbities and slope of eGFR | Baseline |
| Descriptive analyses of demographic data. | Age, sex, urban or rural residence. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients medical history data from Alberta Kidney Disease Network (AKDN) with Type 2 diabetes by chronic kidney disease (CKD) stage and by rate of CKD progression will be collected retrospectively.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Canada |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline |
| Rate of decline in estimated glomerular filtration rate (eGFR) | Retrospectively 3 years |
| Number of patients with CKD dispensed the medication or therapeutic class over a 1-year time period | from January 1, 2018 to December 31, 2018 |
| The proportion of patients with CKD that experience a health outcome of interest over a 1-year time period | from January 1, 2018 to December 31, 2018 |
| Health care resource utilization among patients | from January 1, 2018 to December 31, 2018 |
| Annual average costs among patients | from January 1, 2018 to December 31, 2018 |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |